Project Manager for Module 3 - Consultant

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This is a contract consulting position.

Location: Remote (with occasional travel as needed)

Overview:

We are seeking an experienced Consultant - Project Manager to lead the development of Module 3 of the Common Technical Document (CTD) for a cutting-edge cell and gene therapy product. This role requires expertise in the life sciences industry, specifically in the cell and gene therapy space, with strong project management skills, technical knowledge, and a deep understanding of regulatory requirements. The consultant will be responsible for assembling a multidisciplinary team, creating the Module 3 dossier from scratch, and ensuring its quality and compliance.

Key Responsibilities:

• Project Management:
• Develop and manage a comprehensive project plan for the creation of Module 3, including timelines, deliverables, and milestones
• Assemble and lead a cross-functional team, including subject matter experts (SMEs), technical writers, and quality assurance professionals
• Monitor project progress and ensure adherence to timelines and budget
• Provide regular updates and communicate effectively with stakeholders
• Module 3 Development:
• Lead the compilation and drafting of the Quality section (Module 3) of the CTD, ensuring alignment with regulatory requirements (FDA, EMA, etc.)
• Oversee the collation of data related to manufacturing, control, and quality attributes of the cell and gene therapy product
• Collaborate with SMEs to gather and validate technical content, including Chemistry, Manufacturing, and Controls (CMC) data
• Regulatory Compliance:
• Ensure all documentation complies with applicable regulatory guidelines and standards for cell and gene therapies
• Identify and mitigate risks related to regulatory submission readiness
• Team Leadership:
• Identify and onboard team members with relevant expertise
• Foster collaboration and accountability across team members and stakeholders
• Quality Control:
• Implement rigorous quality control processes to ensure the accuracy, consistency, and completeness of Module 3
• Perform reviews and audits of the document to maintain high standards
• Stakeholder Collaboration:
• Serve as the primary point of contact for internal and external stakeholders regarding Module 3
• Coordinate with regulatory affairs teams to ensure submission readiness

Qualifications:

• Advanced degree (MS, PhD, or equivalent) in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field
• Minimum of 5-7 years of experience in the life sciences industry, with a focus on cell and gene therapy
• Proven expertise in project management and regulatory submissions, particularly in developing Module 3 of the CTD
• Comprehensive knowledge of CMC requirements for cell and gene therapy products
• Experience leading cross-functional teams and managing complex projects from inception to completion
• Strong understanding of FDA, EMA, and ICH guidelines for CTD submissions
• Excellent written and verbal communication skills, with the ability to convey technical information effectively
• PMP certification or equivalent project management training is a plus
  
  

Key Competencies:

• Leadership and team-building skills
• Strong analytical and problem-solving abilities
• Attention to detail and commitment to quality
• Ability to manage multiple priorities in a fast-paced environment
• Adaptability and resilience in navigating complex challenges
  
  

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